Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

NCT05808725 | Completed Phase 1 FDA Drug

• 1 other identifier: ARL-22-073
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to assess the relative bioavailability of Amlodipine for Oral Solution 5 mg of Brillian Pharma Inc. under fasting and fed conditions versus reference product Norvasc 5 mg tablets of Pfizer Labs under fasting in normal, healthy, adult, male, Primary Objective:

1. 1.To compare the relative bioavailability.
2. 2.To assess the food effect in Test product (T1) (Fast) vs Test product (T2) (Fed) Amlodipine Oral Solution 5 mg of Brillian Pharma Inc.

Conditions

Hypertension; Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum observed drug concentration during the study

  1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose

• AUC0-t

  Area under the plasma concentration-time curve measured to the last quantifiable concentration, using the linear trapezoidal rule.

  50 days

• AUC0-inf

  AUC0-t plus additional area extrapolated to infinity, calculated using the formula AUC0-t + Ct/Kel , where Ct is the last measurable drug concentration and Kel is the elimination rate constant.

  1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose

Secondary Outcomes (5)

• Tmax

  6 days

• AUC0-t/AUC0-inf

  1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose

• Residual Area

  1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose

• Kel

  6 days

• t1/2

  6 days

Study Arms (3)

T1 Fasting

EXPERIMENTAL

Giving test product under fasting condition

Drug: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

T2 Fed

EXPERIMENTAL

Giving test product under fed condition

Drug: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

R Fasting

ACTIVE COMPARATOR

Giving reference product under fasting condition

Drug: Norvasc 5 mg tablets of Pfizer Labs

Interventions

Amlodipine Freeze-Dried Powder for Oral Solution 5 mg DRUG

Amlodipine Oral Solution 5 mg is given to T1 Fasting and T2 Fed

Also known as: Amlodipine Oral Solution 5 mg

T1 Fasting; T2 Fed

Norvasc 5 mg tablets of Pfizer Labs DRUG

Norvasc 5 mg is given to R Fasting

Also known as: Amlodipine Besylate 5 mg

R Fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, Healthy

Sponsors & Collaborators

• Brillian Pharma Inc.: lead
• Accutest Research Laboratories (I) Pvt. Ltd.: collaborator

Study Sites (1)

Accutest Research Laboratories (I) Pvt. Ltd.

Vadodara, Gujarat, 390016, India

Location

MeSH Terms

Conditions

Hypertension; Coronary Artery Disease

Interventions

Solutions; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pratikkumar Dilipbhai Asari, M.D.

  Accutest Research Laboratories (I) Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Open Label, Balanced, Three Treatment, Three period, Three Sequence, Single Dose, Crossover design.

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 11, 2023
• Study Start: December 29, 2022
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)